On Tuesday, Dr. Steffen Thirstrup, Chief Medical Officer (CMO) of the European Medicines Agency (EMA), gave a live presentation and Q&A on the topic of ‘psychedelics and their therapeutic use’. Hosted by Alessandro Faia, EMA Press Officer, this LinkedIn Live session discussed the EU regulatory system, its ability to respond to developments in the market, and the types of trial design and data generation needed to facilitate the approval of psychedelic products in the region.
This session was a continuation of a multi-stakeholder workshop that took place on the 16th and 17th of April, which brought together a host of clinicians, academics, regulators, industry experts, and patients to discuss the prerequisites for safe and effective psychedelic product development (See Insights from the European Medicines Agency’s Psychedelics Workshop: A Pα+ Dispatch). Dr. Thirstrup himself was unable to attend this previous session, so this follow-up event gave him the opportunity to contribute his expertise to the discussion.
From the outset, the EMA CMO was keen to highlight that psychedelics are deserving of a ‘second chance’ with regards to mental health research [1]. He then dived into the questions…
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